Veloxis' Phase 3 Trial of LCP-Tacro™ in Stable Kidney Transplant Patients, the 3001 Study, Published Online in the American Journal of Transplantation

HORSHOLM, Denmark, Jan. 3, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S today is announcing that the LCP-Tacro Phase III clinical trial in stable kidney transplant patients, the 3001 study, has been published online in the American Journal of Transplantation. The article reports on the randomized, controlled, multicenter Phase III trial, which demonstrated that LCP-Tacro dosed once-daily was not inferior to the current leading transplant drug, Prograf®, dosed twice-daily. Non-inferiority was determined by a composite endpoint, measured over a year of follow up that included death, graft failure, biopsy-proven acute rejection or loss to follow-up.

Results of this trial demonstrated that patients can be successfully converted from twice-daily Prograf to once-daily LCP-Tacro, which may increase patient compliance. Non-adherence to drug regimens is a contributor to graft failure (Prog. Transplant, 19:277-284, 2009). The results also demonstrated that, over the 12 month study, the daily dose of LCP-Tacro could be lowered significantly compared to the baseline Prograf dose, while the target blood levels remained stable and within target range. This reflected the enhanced bioavailability provided by Veloxis' proprietary MeltDose® formulation. The technology optimizes the formulation and delivery characteristics of the LCP-Tacro product to permit once daily dosing.

"Our study showed thatLCP-Tacro may be a safe and effective once-daily formulation for preventing rejection, and an alternative to currently available twice-daily tacrolimus," said Suphamai Bunnapradist, M.D., Professor of Medicine at David Geffen School of Medicine at UCLA. "LCP-Tacro required lower doses to achieve target levels in the blood, had similar rates of adverse events, and demonstrated non-inferiority to the twice daily regimen of tacrolimus in stable patients."

William Polvino, M.D. and chief executive officer of Veloxis added, "We have reached another milestone by the publication of the 3001 study in the American Journal of Transplantation. We are now looking forward to completing the 3002 study in de novo kidney transplant patients and releasing top-line data in mid-2013."

Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP‐Tacro™ is an investigational drug that it is being developed as a once‐daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak‐to‐trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.

About Veloxis Pharmaceuticals

Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is LCP‐Tacro™ for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low‐scale up costs. Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO.